Neurotech International Ltd. · ASX:NTI
Neurotech International — NWR Virtual Healthcare Conference 2024
23 slides from Neurotech International's conference presentation, Mar 21, 2024
Slide 1: Neurotech Presentation at NWR Virtual Healthcare Conference (ASX Announcement)
ASX Announcement 21 March 2024 Neurotech Presentation at NWR Virtual Healthcare Conference Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”), a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders, will today present
Slide 2: Improving Lives
For personal use only Improving Lives Dr Tom Duthy NWR Virtual Healthcare Conference Executive Director 21 March 2024
Slide 3: Disclaimer
Disclaimer IMPORTANT INFORMATION Purpose of presentation: This presentation (including this document, any related video or oral These events are, as at the date of this presentation, expected to take place, but there cannot be any guarantee that such will occur as anticipated, or at all, given that
Slide 4: Neurotech is a clinical-stage biopharmaceutical development company
Neurotech is a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders For personal use only NTI164 exclusive worldwide Novel oral Patents Pending – biopharmaceutical licence for neurological Use, Composition disorders cannabinoid platform (NTI
Slide 5: Corporate / Capital Summary
Corporate / Capital Summary $0.09 $82.6M $4.5M ~1,900 For personal use only Share price (as at 19 Mar 2024) Market Cash as 31 Dec ‘23 No. of shareholders capitalisation 917.4M 101M^ $6.5M 53% Share on issue NTIOA (13.5c, FY23 R&D Exp. Top 20 Holders (up from $2.6M in FY22) 65M) + Other Options ^Opti
Slide 6: Neurotech Four Core Strategies
Neurotech Four Core Strategies For personal use only Focus On Rare Focus on Paediatric Patients Neurological Disorders with Neuroinflammation Focus on Partnering with Focus On Drug Product Key Opinion Leaders / Development Clinicians 5
Slide 7: Summary of Strategy
Summary of Strategy Implementation Potential Group Strategy to Development Regulatory Levers Commercialisation Examples* Current 2016 2018/9 2021 For personal use only Phase I/II PANDAS/PANS Pre-IND Feedback IND Orphan Drug Designation Priority Review Phase III Trials 2021: US$7.2 Phase I/II Billion
Slide 8: Therapeutic Agent: NTI164
Therapeutic Agent: NTI164 THC < 0.3% For personal use only Convenient 1x or 2x (split dose) High potency, Broad Spectrum Cannabinoid Formulation in Oil, C. Major constituent Cannabidiolic oral formulation in oil, ideal acid (CBDA) format for pediatric patients sativa L. (Plant Derived) 20mg/kg (CBDA
Slide 9: Developing NTI164 as a Therapeutic Agent
Developing NTI164 as a Therapeutic Agent NTI164 to be registered as a prescription-only medicine For personal use only Neurotech investment into clinical trials to show safety and benefit Regulatory approval(s) will allow Neurotech to make a medical claim Significantly higher pricing and reimburseme
Slide 10: Clinical Focus
Clinical Focus ASD PANDAS/PANS Strong Scientific Rationale for NTI164 Cerebral Palsy • Anti-inflammatory effects + safety Rett Syndrome • Clinician support For personal use only • High Patient/Caregiver interest Neurological & Neuroinflammation Lack of effective treatments Rare / Orphan Paediatric O
Slide 11: Clinical Pipeline – 2024
Clinical Pipeline – 2024 Pre-Clinical Phase I/II Phase II/III For personal use only NTI164 NTI164 NTI164 Combination Therapies Prednisone, Diclofenac, Other Cerebral Palsy ASD Other Licensed NTI164 Strains PANDAS / PANS1 Pipeline (2020/1) NTI164 ASD NTI164 Combination Therapies (90 week+ open label
Slide 12: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) PREVALENCE OF ASD TREATMENT MARKET SIZE ~1 in 44 children 2 in the US1 US$2.0bn 2 Approved Drugs (* limited use) For personal use only Risperidone, Aripiprazole Market Current Treatment Clinical Trial ASD is a serious Huge unmet medical Initial Focus of NTI164 – A full
Slide 13: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) • Phase I/II Clinical Trial reported data out • 34% of the 550,000 NDIS participants have • Prevalence of ASD in Australia est. 1 in 50 to 52 weeks of treatment ASD, 40% ≤ 14 years old (860,000 by 2030) • 40-fold increase in 20 years5 For personal use only World first
Slide 14: Data Comparison & Context - Risperidone
Data Comparison & Context - Risperidone NTI164 Phase RISPERIDONE I/II (n=11) For personal use only • -1.1 change at 20 weeks (p=0.005), 26% improvement • (n=96): -1.0 from baseline at 12 months1 • -1.3 change at 52 weeks (p=0.032) CGI-Severity of illness • (n=38): -0.7 from baseline at 48 weeks2 • ~
Slide 15: PANDAS/PANS
PANDAS/PANS Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Phase I/II reported: 15 patients with moderate-severe PANDAS/PANS Attractive Clinical and Market Dynamics recruited,12-week data
Slide 16: Rett Syndrome Market Dynamics
Rett Syndrome Market Dynamics Significant Market Single Approved Therapy Valuation/Pricing Benchmarks For personal use only 6,000-9,000 2,000-3,000 9,000-14,000 200 • First FDA approved therapy (March 2023) • 17-26k patients in USA, Europe, Japan, • Neuren (ASX:NEU) license deal with Acadia • Est. d
Slide 17: Rett Syndrome Trial Design (NTIRTT1)
Rett Syndrome Trial Design (NTIRTT1) Primary Endpoint For personal use only • Clinical Global Impression – Improvement (CGI-I) Secondary Endpoints • Rett Syndrome Behaviour Questionnaire (RSBQ) • Rett Syndrome: Symptom Index Score (RTT-SIS) • RTT- Clinician Domain Specific Concerns – Visual Analog S
Slide 18: Safety Data of Interest
Safety Data of Interest Safety Over 12 Weeks: Key Focal Points For personal use only 12% pts with >7% weight loss Weight Loss Kidney/Liver Function No significant weight change noted for Neurotech ASD & PANDAS/PANS Phase I/II trials All normal across Neurotech’s previous ASD (90 weeks+) and PANDAS/P
Slide 19: Cerebral Palsy
Cerebral Palsy Interventions ideally seek to: improve gross motor function, to increase participation at a social role level, to improve comfort, to improve the ease of care by others or to improve About the overall quality of life of the individual • Most common motor disability in childhood, abnor
Slide 20: Our Target Markets
Our Target Markets Lack of effective therapies, significant unmet medical need Annual Drug Therapy Market opportunity US$2 billion* US$2 billion US$1.4 billion1 US$4.3 billion For personal use only Orphan Orphan Autism Spectrum Disorder (ASD) Rett Syndrome PANDAS/PANS Cerebral Palsy (CP) • Prevalenc
Slide 21: Key Milestones – NTI164
Key Milestones – NTI164 1H CY2023 2H CY2023 • Final results of ASD Phase I/II Clinical Trial (52 weeks) • Commence Phase I/II Clinical Trial in Rett Syndrome For personal use only • Commencement of Patient Recruitment PANDAS/PANS Phase I/II • Results of PANDAS/PANS Phase I/II Clinical Trial Clinical
Slide 22: Outlook
Outlook • Focus on rare paediatric neurological disorders • Accelerated clinical development via rapid & cost-effective proof of concept Phase I/II clinical trials in Australia for new paediatric neurological For personal use only disorders (PANDAS/PANS, Rett and CP) • Two further clinical trial rea
Slide 23: Contact Details
For personal use only Contact Details Dr Tom Duthy Executive Director [email protected] +61 402 493 727 *This presentation has been authorised by the Board of Neurotech International Limited www.neurotechinternational.com www.mentetech.com Neurotech International Limited (ASX: NTI) 22
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